Registered Zambia · ZAMRA

Uroka Capsules

Dutadteride 0.5mg

385/019

What it does

Dutasteride is a medication used to treat conditions related to an enlarged prostate.

Commonly used for: enlarged prostate (benign prostatic hyperplasia), prostate gland problems

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
385/019
Registration date
2021-05-12
Expiry date
2026-05-12
Status
Registered/Compliant
Active ingredient
Dutadteride 0.5mg
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Mega Lifesciences
Country of origin
Thailand
Manufacturer location
515, 1 Soi 8 D, Tambon Phraeksa, Amphoe Mueang Samut Prakan, Chang Wat Samut Prakan 10280, Thailand

Source: Zambia Medicines Regulatory Authority · fetched 2026-03-11 23:59:35 · updated 2026-05-11 08:06:43

Disclaimer: This information is sourced from Zambia Medicines Regulatory Authority (Zambia). Always consult a qualified healthcare professional before using any medication.

About this medicine

Dutasteride is a medication used to treat conditions related to an enlarged prostate.

What it treats

  • enlarged prostate (benign prostatic hyperplasia)
  • prostate gland problems

How it works

It works by reducing the size of the prostate, helping to relieve symptoms such as difficulty urinating.

Who it's for

It is for adult men who have symptoms related to an enlarged prostate.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: dutadteride

Dutasteride is a 5-alpha-reductase inhibitor primarily used in the treatment of benign prostatic hyperplasia (BPH). By inhibiting the enzyme 5-alpha-reductase, it prevents the conversion of testosterone to dihydrotestosterone (DHT), a hormone that contributes to prostate growth. This reduction in DHT levels can alleviate urinary symptoms associated with BPH and may also have implications for prostate cancer prevention.

Indications

  • Benign prostatic hyperplasia (BPH)
  • Prostate enlargement

Dosage

Children: Not indicated for paediatric use.

Adults: Refer to specific dosing guidelines in the BNF or consult a healthcare professional for appropriate dosing.

Mechanism of action

Dutasteride specifically inhibits both type I and type II isoforms of 5-alpha-reductase, which are responsible for the conversion of testosterone to dihydrotestosterone (DHT). By decreasing DHT levels, dutasteride reduces prostate size and improves urinary flow, thus addressing symptoms of BPH.

Pharmacodynamics

Dutasteride's action leads to a significant reduction in serum DHT levels, with a decrease of approximately 90% in most patients. This reduction in DHT is associated with a decrease in prostate volume and improvement in urinary symptoms. The onset of action may take several months, with maximum effects typically observed after 6 to 12 months of treatment.

Pharmacokinetics

Dutasteride is well absorbed following oral administration, with food having no significant effect on its bioavailability. The drug has a large volume of distribution and is highly protein-bound. Its elimination half-life is prolonged, averaging about 5 weeks, due to its lipophilicity and extensive tissue binding. Dutasteride is metabolized primarily in the liver by cytochrome P450 enzymes, and its metabolites are excreted primarily in feces.

Contra-indications

  • Hypersensitivity to dutasteride or any component of the formulation
  • Pregnant women or women who may become pregnant

Adverse effects

  • Decreased libido
  • Erectile dysfunction
  • Ejaculation disorders
  • Gynecomastia
  • Breast tenderness
  • Allergic skin reactions

Interactions

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase the levels of dutasteride
  • CYP3A4 inducers (e.g., rifampicin) may decrease the effectiveness of dutasteride

Precautions

  • Use with caution in patients with hepatic impairment
  • Monitor for signs of prostate cancer in patients receiving dutasteride
  • Not recommended for use in children

Pregnancy

Dutasteride is contraindicated in pregnancy due to potential risk to the developing fetus, particularly affecting male genital development.

Breast-feeding

It is not known if dutasteride is excreted in human milk; caution is advised when administering to nursing mothers.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Capsules: 0.5 mg

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.